Neff G10546Recalls & reported problems
Cook Incorporated · Neff Percutaneous Access Set With Hydrophilic Coating and Nitinol Wire Guide · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002105461), received between Jan 29, 2018 and Apr 3, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Fracture1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING PREOPERATIVE PREPARATION, THE NEFF PERCUTANEOUS ACCESS SET PACKAGE WAS FOUND TO BE UNSEALED. A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762257 ↗MalfunctionMar 16, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED A COOK NEFF PERCUTANEOUS ACCESS SET WAS CONTAMINATED. A PARTICLE WAS FOUND INSIDE THE PACKAGING OF THE DEVICE BY THE DISTRIBUTOR. NO PATIENT CONTACT WAS MADE. THEREFORE, NO ADVERSE EFFECTS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16558821 ↗InjuryJan 29, 2018Fracture; Fracture
THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING THE USE OF THE NEFF PERCUTANEOUS ACCESS SET, THE TIP OF THE WIRE GUIDE COULD NOT BE RETRACTED THROUGH THE NEEDLE. IT WAS REPORTEDLY STUCK AND DETACHED FROM THE REST OF THE GUIDE, AND BECAME LODGED IN THE PATIENT'S RIGHT RENAL PARENCHYMA. AS A CONSEQUENCE, THE TIP OF THE WIRE GUIDE REMAINED IN THE PATIENT AND WAS NOT RETRIEVED. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE PERFORMED TO ATTEMPT TO RECOVER THE FRAGMENT OF THE WIRE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 7226323 ↗
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- Centeze Centesis Catheter DRC-002-06Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- Centeze Centesis Catheter DRC-002-05Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- IV Administration Set 490062B. Braun Medical Inc. · ACCESSORIES, CATHETER1 recall0 reports
- Neff G10544Cook Incorporated · ACCESSORIES, CATHETER45 reports
- Cook G06299Cook Incorporated · ACCESSORIES, CATHETER18 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.